Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as lufepirsen high dose
Lufepirsen · 1 trial · 1 indication
The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).
| Arm | Type | Description |
|---|---|---|
| NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration | EXPERIMENTAL | Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON Vehicle (ophthalmic gel) | PLACEBO_COMPARATOR | Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only) | EXPERIMENTAL | Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only). |
| Name | Type | Description |
|---|---|---|
| lufepirsen high dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
| Vehicle | DRUG | Matching vehicle without lufepirsen. |
| lufepirsen low dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
Inclusion Criteria: 1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatme...
Lufepirsen high dose is an investigational small molecule being developed for Persistent Corneal Epithelial Defect (PCED), a condition in ophthalmology. It is formulated as an ophthalmic gel and is currently in Phase 2 clinical development. The drug is not yet approved and remains under investigation for this indication.
Lufepirsen high dose targets GJA1, a gene that encodes connexin 43, a gap junction protein. As an antisense oligonucleotide (ASO), it is designed to modulate GJA1 expression. This molecular target is being studied for its potential role in treating Persistent Corneal Epithelial Defect.
Lufepirsen high dose is being developed by Glaukos Corporation, a company traded on the NYSE under the ticker GKOS. Glaukos is conducting clinical research on this ophthalmic gel for Persistent Corneal Epithelial Defect.
Lufepirsen high dose is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting participants to evaluate the safety and efficacy of the treatment for Persistent Corneal Epithelial Defect.
Lufepirsen high dose is being studied in one active Phase 2 clinical trial with the identifier NCT05966493. This randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with Persistent Corneal Epithelial Defect. The trial plans to enroll 84 participants across the United States, Germany, Italy, and Spain.
Yes, lufepirsen high dose is the same as NEXAGON. In clinical trials, the drug is referred to as NEXAGON (lufepirsen ophthalmic gel). Both names refer to the same investigational treatment being developed for Persistent Corneal Epithelial Defect.